Virtual Reality SimulationNCT06917755
The Impact of Immersive Virtual Reality Training in Thyroid Surgery
A study testing Virtual Reality Training in Thyroid Surgery and Convetional Training in people with Virtual Reality Simulation and Thyroid Surgery, run by G.Gennimatas General Hospital at 1 site in Greece.
Trial summary
Up to this date, there have been no reports on virtual reality (VR) training in thyroid surgery. The purpose of this study is to determine the impact of VR training in residents' education. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality Simulation, Thyroid Surgery
- What is being tested?
- Virtual Reality Training in Thyroid Surgery and Convetional Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGreece
- Study dates
- 20 Feb 2025to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residents of the 2nd Surgical Department of Aristotle University of Thessaloniki
- Residents who have completed their 1st year of training programm.
Who cannot join
- Disagreement of participants' randomisation
- Prolonged surgical time of completion
- Participant's experience beyond the included limits
- Participants who are completely incapable of using VR devices or have specific helath restrictions of using these
- Patients with complex thyroid disease such as recurrent disease, concominant primary hyperparathyroidism, lymph node disease or metastasis, Graves disease and intrathoracic goiter
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
"Georgios Gennimatas" General Hospital of Thessaloniki
Thessaloniki, 54635
Giannis Koutelidakis, Professor of Surgery, +306944697077, iokoutel@gmail.com
Nikolaos Voloudakis, Academic Fellow
About this study
Official title: The Impact of Immersive Virtual Reality Training in Thyroid Surgery: A Prospective Randomized Controlled Trial
Up to this date, there have been no reports on virtual reality (VR) training in thyroid surgery. The purpose of this study is to determine the impact of VR training in residents' education.
Investigators intend to include general surgery residents in the trial, subgrouped in a VR training group and another one with traditional learning, utilizing a technical textbook as a control. For the purpose of this study, a commercial available VR mask will be given for training in the VR group. Randomization will be used to secure balance in the distribution of residents according to their experience. The task which will be examined include surgical steps from neck incision up to the placement of the C-IONM electrode and will be evaluated by a blinded FEBS certified endocrine surgeon in the operating theatre.
Training superiority will be assessed by the outcome measures of Objective Structured Assessment of Technical Skills (OSATS) score, need for the main surgeon to intervene (NTI), verbal answers and time to task completion. Participants will complete questionnaires regarding satisfaction of the whole educational process.
- Conditions
- Virtual Reality Simulation, Thyroid Surgery
- Being tested
- Virtual Reality Training in Thyroid Surgery, Convetional Training
- Keywords
- Endocrine Surgery, Thyroid Surgery, Virtual Reality, Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Training in Thyroid SurgeryOther
Participants will use an application in an Immersive Virtual Reality environment. In this module, the participant will be the chief surgeon and will be guided to accomplise the first steps of thyroidectomy: from neck incision until continious neuromonitoring device placement in vagus nerve.
Convetional TrainingOther
This intervation consists of traditional methods of training. Participants will read specific chapters of a technical book specialised in Endocrine Surgery (Atlas of Thyroid Surgery- Alexander Shifrin). Also, they will be provided with videos of the clinic's archive which will support them with specific surgical steps : neck incision up to Continious Neuromonitoring Device placement on Vagus nerve.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | This group will be trained via traditional methods which consists of reading specific chapters of a technical book specialised in Endocrine Surgery (Atlas of Thyroid Surgery- Alexander Shifrin). Also, this group will be provided with videos of the clinic's archive which will support them with specific surgical steps : neck incision up to Continious Neuromonitoring Device placement on Vagus nerve. Receives: Other: Convetional Training |
| Virtual Reality Group | Experimental | Participants of this group will be provided with a VR device- MetaQuest3- with an application which will guide them to completion of specific surgical steps from incision up to Continious Neuromonitoring Device placement on Vagus nerve. Receives: Other: Virtual Reality Training in Thyroid Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSATS Score
As the Primary Outcome Measure of the study will be the OSATS(Objective Structured Assessment of Technical Skills) score of participants in each group. Statistical significance of this score between groups will be measured.OSATS is a worlwide tool which measure surgical performance using 7 measurements and scoring system from 7 to 35. Its main advantage is that can measure with a quantitative manner surgical performance.
Measured: From enrollment to the end of assesment of the FEBS certicied surgeon at 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start20 Feb 2025
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Virtual Reality SimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G.Gennimatas General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anestis Basios, G.Gennimatas General Hospital
- Investigators
- Ioannis Koutelidakis, Professor of Surgery, Study director, 2nd Surgical Department of Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917755
- Sponsor's protocol ID
- 17010/2910-2024
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any Individual Participant's Data could be shared upon request.
Publications
Ochs V, Saad B, Taha-Mehlitz S, Staubli S, Neumann K, Fischer L, Honaker MD, Lamm S, Rosenberg R, Taha A, Cattin PC. An analysis of virtual reality in abdominal surgery-A scoping review. Int J Med Robot. 2024 Feb;20(1):e2623. doi: 10.1002/rcs.2623.
PubMed 38375774Rizzetto F, Bernareggi A, Rantas S, Vanzulli A, Vertemati M. Immersive Virtual Reality in surgery and medical education: Diving into the future. Am J Surg. 2020 Oct;220(4):856-857. doi: 10.1016/j.amjsurg.2020.04.033. Epub 2020 Apr 30. No abstract available.
PubMed 32386709Long AS, Almeida MN, Chong L, Prsic A. Live Virtual Surgery and Virtual Reality in Surgery: Potential Applications in Hand Surgery Education. J Hand Surg Am. 2023 May;48(5):499-505. doi: 10.1016/j.jhsa.2023.01.004. Epub 2023 Feb 9.
PubMed 36764847Portelli M, Bianco SF, Bezzina T, Abela JE. Virtual reality training compared with apprenticeship training in laparoscopic surgery: a meta-analysis. Ann R Coll Surg Engl. 2020 Nov;102(9):672-684. doi: 10.1308/rcsann.2020.0178. Epub 2020 Aug 21.
PubMed 32820649Nassar AK, Al-Manaseer F, Knowlton LM, Tuma F. Virtual reality (VR) as a simulation modality for technical skills acquisition. Ann Med Surg (Lond). 2021 Oct 27;71:102945. doi: 10.1016/j.amsu.2021.102945. eCollection 2021 Nov.
PubMed 34840738Ntakakis G, Plomariti C, Frantzidis C, Antoniou PE, Bamidis PD, Tsoulfas G. Exploring the use of virtual reality in surgical education. World J Transplant. 2023 Feb 18;13(2):36-43. doi: 10.5500/wjt.v13.i2.36.
PubMed 36908307Mishra R, Narayanan MDK, Umana GE, Montemurro N, Chaurasia B, Deora H. Virtual Reality in Neurosurgery: Beyond Neurosurgical Planning. Int J Environ Res Public Health. 2022 Feb 2;19(3):1719. doi: 10.3390/ijerph19031719.
PubMed 35162742Falguiere A, LeGruiec C, Herry H, Genest-Beucher S, Dessus JM, Boisrame S. Contribution of virtual reality in oral surgery: A literature review. J Stomatol Oral Maxillofac Surg. 2021 Sep;122(4):405-410. doi: 10.1016/j.jormas.2021.02.004. Epub 2021 Feb 18.
PubMed 33610770Arjomandi Rad A, Vardanyan R, Thavarajasingam SG, Zubarevich A, Van den Eynde J, Sa MPBO, Zhigalov K, Sardiari Nia P, Ruhparwar A, Weymann A. Extended, virtual and augmented reality in thoracic surgery: a systematic review. Interact Cardiovasc Thorac Surg. 2022 Jan 18;34(2):201-211. doi: 10.1093/icvts/ivab241.
PubMed 34542639Verhey JT, Haglin JM, Verhey EM, Hartigan DE. Virtual, augmented, and mixed reality applications in orthopedic surgery. Int J Med Robot. 2020 Apr;16(2):e2067. doi: 10.1002/rcs.2067. Epub 2020 Feb 6.
PubMed 31867864Lohre R, Bois AJ, Athwal GS, Goel DP; Canadian Shoulder and Elbow Society (CSES). Improved Complex Skill Acquisition by Immersive Virtual Reality Training: A Randomized Controlled Trial. J Bone Joint Surg Am. 2020 Mar 18;102(6):e26. doi: 10.2106/JBJS.19.00982.
PubMed 31972694Lohre R, Bois AJ, Pollock JW, Lapner P, McIlquham K, Athwal GS, Goel DP. Effectiveness of Immersive Virtual Reality on Orthopedic Surgical Skills and Knowledge Acquisition Among Senior Surgical Residents: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2031217. doi: 10.1001/jamanetworkopen.2020.31217.
PubMed 33369660Basios A, Voloudakis N, Atmatzidis S, Velikoudi M, Bellou E, Vamvakidis K, Papaziogas B, Koutelidakis I. The impact of immersive virtual reality training in thyroid surgery: a prospective randomized controlled trial. Updates Surg. 2025 Dec;77(8):2535-2543. doi: 10.1007/s13304-025-02387-8. Epub 2025 Aug 29.
PubMed 40879873
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Immersive Virtual Reality Training in Thyroid Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06917755
- Acronym / sponsor ID
- 17010/2910-2024
- Conditions
- Virtual Reality Simulation, Thyroid Surgery
- Keywords
- Endocrine Surgery, Thyroid Surgery, Virtual Reality, Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- G.Gennimatas General HospitalUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to this date, there have been no reports on virtual reality (VR) training in thyroid surgery. The purpose of this study is to determine the impact of VR training in residents' education.
Investigators intend to include general surgery residents in the trial, subgrouped in a VR training group and another one with traditional learning, utilizing a technical textbook as a control. For the purpose of this study, a commercial available VR mask will be given for training in the VR group. Randomization will be used to secure balance in the distribution of residents according to their experience. The task which will be examined include surgical steps from neck incision up to the placement of the C-IONM electrode and will be evaluated by a blinded FEBS certified endocrine surgeon in the operating theatre.
Training superiority will be assessed by the outcome measures of Objective Structured Assessment of Technical Skills (OSATS) score, need for the main surgeon to intervene (NTI), verbal answers and time to task completion. Participants will complete questionnaires regarding satisfaction of the whole educational process.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Convetional TrainingThis group will be trained via traditional methods which consists of reading specific chapters of a technical book specialised in Endocrine Surgery (Atlas of Thyroid Surgery- Alexander Shifrin). Also, this group will be provided with videos of the clinic's archive which will support them with specific surgical steps : neck incision up to Continious Neuromonitoring Device placement on Vagus nerve. |
| Virtual Reality Group | Experimental | Other: Virtual Reality Training in Thyroid SurgeryParticipants of this group will be provided with a VR device- MetaQuest3- with an application which will guide them to completion of specific surgical steps from incision up to Continious Neuromonitoring Device placement on Vagus nerve. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Residents of the 2nd Surgical Department of Aristotle University of Thessaloniki
- Residents who have completed their 1st year of training programm.
Key exclusion criteria (5 listed)
- Disagreement of participants' randomisation
- Prolonged surgical time of completion
- Participant's experience beyond the included limits
- Participants who are completely incapable of using VR devices or have specific helath restrictions of using these
- Patients with complex thyroid disease such as recurrent disease, concominant primary hyperparathyroidism, lymph node disease or metastasis, Graves disease and intrathoracic goiter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Training in Thyroid SurgeryParticipants will use an application in an Immersive Virtual Reality environment. In this module, the participant will be the chief surgeon and will be guided to accomplise the first steps of thyroidectomy: from neck incision until continious neuromonitoring device placement in vagus nerve. | Other | Virtual Reality Group |
| Convetional TrainingThis intervation consists of traditional methods of training. Participants will read specific chapters of a technical book specialised in Endocrine Surgery (Atlas of Thyroid Surgery- Alexander Shifrin). Also, they will be provided with videos of the clinic's archive which will support them with specific surgical steps : neck incision up to Continious Neuromonitoring Device placement on Vagus nerve. | Other | Control Group |
Primary outcome
OSATS Score
Time frame: From enrollment to the end of assesment of the FEBS certicied surgeon at 1 day
As the Primary Outcome Measure of the study will be the OSATS(Objective Structured Assessment of Technical Skills) score of participants in each group. Statistical significance of this score between groups will be measured.OSATS is a worlwide tool which measure surgical performance using 7 measurements and scoring system from 7 to 35. Its main advantage is that can measure with a quantitative manner surgical performance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Background: PubMed 38375774Ochs V, Saad B, Taha-Mehlitz S, Staubli S, Neumann K, Fischer L, Honaker MD, Lamm S, Rosenberg R, Taha A, Cattin PC. An analysis of virtual reality in abdominal surgery-A scoping review. Int J Med Robot. 2024 Feb;20(1):e2623. doi: 10.1002/rcs.2623.
- Background: PubMed 32386709Rizzetto F, Bernareggi A, Rantas S, Vanzulli A, Vertemati M. Immersive Virtual Reality in surgery and medical education: Diving into the future. Am J Surg. 2020 Oct;220(4):856-857. doi: 10.1016/j.amjsurg.2020.04.033. Epub 2020 Apr 30. No abstract available.
- Background: PubMed 36764847Long AS, Almeida MN, Chong L, Prsic A. Live Virtual Surgery and Virtual Reality in Surgery: Potential Applications in Hand Surgery Education. J Hand Surg Am. 2023 May;48(5):499-505. doi: 10.1016/j.jhsa.2023.01.004. Epub 2023 Feb 9.
- Background: PubMed 32820649Portelli M, Bianco SF, Bezzina T, Abela JE. Virtual reality training compared with apprenticeship training in laparoscopic surgery: a meta-analysis. Ann R Coll Surg Engl. 2020 Nov;102(9):672-684. doi: 10.1308/rcsann.2020.0178. Epub 2020 Aug 21.
- Background: PubMed 34840738Nassar AK, Al-Manaseer F, Knowlton LM, Tuma F. Virtual reality (VR) as a simulation modality for technical skills acquisition. Ann Med Surg (Lond). 2021 Oct 27;71:102945. doi: 10.1016/j.amsu.2021.102945. eCollection 2021 Nov.
- Background: PubMed 36908307Ntakakis G, Plomariti C, Frantzidis C, Antoniou PE, Bamidis PD, Tsoulfas G. Exploring the use of virtual reality in surgical education. World J Transplant. 2023 Feb 18;13(2):36-43. doi: 10.5500/wjt.v13.i2.36.
- Background: PubMed 35162742Mishra R, Narayanan MDK, Umana GE, Montemurro N, Chaurasia B, Deora H. Virtual Reality in Neurosurgery: Beyond Neurosurgical Planning. Int J Environ Res Public Health. 2022 Feb 2;19(3):1719. doi: 10.3390/ijerph19031719.
- Background: PubMed 33610770Falguiere A, LeGruiec C, Herry H, Genest-Beucher S, Dessus JM, Boisrame S. Contribution of virtual reality in oral surgery: A literature review. J Stomatol Oral Maxillofac Surg. 2021 Sep;122(4):405-410. doi: 10.1016/j.jormas.2021.02.004. Epub 2021 Feb 18.
- Background: PubMed 34542639Arjomandi Rad A, Vardanyan R, Thavarajasingam SG, Zubarevich A, Van den Eynde J, Sa MPBO, Zhigalov K, Sardiari Nia P, Ruhparwar A, Weymann A. Extended, virtual and augmented reality in thoracic surgery: a systematic review. Interact Cardiovasc Thorac Surg. 2022 Jan 18;34(2):201-211. doi: 10.1093/icvts/ivab241.
- Background: PubMed 31867864Verhey JT, Haglin JM, Verhey EM, Hartigan DE. Virtual, augmented, and mixed reality applications in orthopedic surgery. Int J Med Robot. 2020 Apr;16(2):e2067. doi: 10.1002/rcs.2067. Epub 2020 Feb 6.
- Background: PubMed 31972694Lohre R, Bois AJ, Athwal GS, Goel DP; Canadian Shoulder and Elbow Society (CSES). Improved Complex Skill Acquisition by Immersive Virtual Reality Training: A Randomized Controlled Trial. J Bone Joint Surg Am. 2020 Mar 18;102(6):e26. doi: 10.2106/JBJS.19.00982.
- Background: PubMed 33369660Lohre R, Bois AJ, Pollock JW, Lapner P, McIlquham K, Athwal GS, Goel DP. Effectiveness of Immersive Virtual Reality on Orthopedic Surgical Skills and Knowledge Acquisition Among Senior Surgical Residents: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2031217. doi: 10.1001/jamanetworkopen.2020.31217.
- Individual participant dataSharing planned: Yes. Any Individual Participant's Data could be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ioannis Koutelidakis, Professor of Surgery study director
2nd Surgical Department of Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Training in Thyroid Surgery and Convetional Training in people with Virtual Reality Simulation and Thyroid Surgery, run by G.Gennimatas General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefanos Atmatzidis, Assistant Professor of Surgery (+306977095756, atmatzidis.stef@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSATS Score (time frame: From enrollment to the end of assesment of the FEBS certicied surgeon at 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06917755, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.